Regulatory
Bioinformatic software is the basis for development in the automated relevance-based detection of blood-stream infections
Bactiguard’s indwelling urinary catheters are now approved for reimbursement in the Netherlands, which means that healthcare providers in the home care market can provide patients with Bactiguard’s products for infection prevention and improve their quality of life.
Shares of ACADIA Pharmaceuticals are up nearly 70% after the company announced it halted a Phase III psychosis trial early after its Parkinson’s disease drug Nuplazid hit primary endpoints and positioned the company to seek another potential regulatory approval.
The U.S. Food and Drug Administration (FDA) gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
In China, much like the United States, it is incredibly difficult to obtain a patent for a diagnostic method.
Global Blood Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).
CDC Awarding Opioid Misuse Prevention Grants Directly to Local Health Departments for the First Time
The Centers for Disease Control and Prevention announced the recipients of its Overdose Data to Action grants, including those in 17 local jurisdictions.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission has approved the expanded use of ustekinumab for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Polyphor AG focused on the discovery and development of immuno-oncology compounds and a new class of antibiotics, publishes today its financial results for the first half of 2019 and announces a realignment of the strategy.
Recce Pharmaceuticals Ltd announced advances in scaled manufacture and drug quality following positive Food and Drug Administration feedback to its Chemistry, Manufacturing, and Controls data pack.
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